Hypotension News and Research

Eli Lilly and Company and Merck, known as MSD outside the United States and Canada, today announced another immuno-oncology collaboration that will evaluate abemaciclib (LY2835219), Lilly's cyclin-dependent kinase (CDK) 4 and 6 inhibitor, and Merck's KEYTRUDA (pembrolizumab) in a Phase I study across multiple tumor types.

Eli Lilly and Company and Merck, known as MSD outside the United States and Canada, today announced the extension of an existing collaboration to evaluate the safety and efficacy of the combination of Lilly's ALIMTA (pemetrexed for injection) and Merck's KEYTRUDA (pembrolizumab) in a pivotal Phase III study in first-line nonsquamous non-small cell lung cancer (NSCLC).

Using intensive treatment to lower blood pressure below currently recommended targets significantly reduces rates of major cardiovascular events like stroke and heart attack among a wide range of high-risk patients, according to a large meta-analysis involving almost 45000 individuals, published in The Lancet.

Jackson T. Wright Jr., MD, PhD, and researchers from University Hospitals Case Medical Center presented new results from the Systolic Blood Pressure Intervention Trial (SPRINT) showing that in patients at high risk for cardiovascular events, targeting a systolic blood pressure of less than 120 mm Hg resulted in lower rates of fatal and non-fatal major events or death compared to targeting systolic blood pressure to the usually recommended target of less than 140 mm Hg.

Researchers from Brooke Army Medical Center in San Antonio, Texas, evaluated the rapid response system (RRS) training program on call rates and code blue events and found significant improvements were made in staff awareness and patient outcomes.

Sprout Pharmaceuticals, Inc., a division of Valeant Pharmaceuticals North America LLC, announced today that Addyi, a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, is now available in the United States through certified physicians and pharmacies.

Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration granted approval of Praxbind (idarucizumab). PRAXBIND is indicated for patients treated with Pradaxa (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.

BioDelivery Sciences International, Inc. announced that the U.S. Food and Drug Administration has approved the company's Supplemental New Drug Application (sNDA) for a manufacturing specification change for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII).

"We are pleased to receive positive CHMP opinions for Kyprolis and BLINCYTO as this is an important step in providing new treatment options for patients in Europe with rare forms of cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

People who get dizzy several minutes after standing up may be at risk of more serious conditions and even an increased risk of death, according to new research published in the September 23, 2015, online issue of Neurology, the medical journal of the American Academy of Neurology.

Amgen and Xencor, Inc. announced today that the two companies have entered into a research and license agreement to develop and commercialize novel therapeutics in the areas of cancer immunotherapy and inflammation.

Valeant Pharmaceuticals International, Inc. and Sprout Pharmaceuticals, Inc. today announced that they have entered into a definitive agreement under which a wholly-owned subsidiary of Valeant will acquire Sprout, on a debt-free basis, for approximately $1 billion in cash, plus a share of future profits based upon the achievement of certain milestones.

Hospira today announced that Inflectra (infliximab), the first monoclonal antibody (mAb) biosimilar therapy, has been registered in Australia. This registration paves the way for the Federal Government to reduce the cost of some of the most expensive medicines on the Pharmaceutical Benefits Scheme (PBS).

United Therapeutics Corporation announced today that the European Commission (EC) has granted Marketing Authorisation for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT).

BioDelivery Sciences International, Inc. announced the approval by the U.S. Food and Drug Administration of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant.

There have been clear statements from regulatory bodies that have increased the pressure on pharmaceutical companies to go electronic with their records and ensure a high level of data integrity in all areas of the pharmaceutical industry.

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